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FDA Unveils Plausible Mechanism Framework Guidance

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FDA issues a draft guidance entitled Considerations for the Use of the Plausible Mechanism Framework to Develop Individualized The...

Calquence Combo OKd for Leukemia, Lymphoma

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FDA approves AstraZenecas Calquence (acalabrutinib) for use in combination with AbbVie and Genentechs Venclexta (venetoclax), a ch...

Novo Nordisk Obesity Drug Misses Endpoint

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Novo Nordisk says its experimental obesity drug CagriSema delivered substantial weight loss in a head-to-head late-stage trial but...

Industry Vet Named Head of FDA Digital Health Center

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FDA appointed a veteran artificial intelligence executive to lead its digital health policy unit, signaling a sharper regulatory f...

DTC Scrutiny Accelerating in 2026: Mintz

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A Mintz legal update says FDA appears to be sustaining and in some cases accelerating its scrutiny of prescription drug advertis...

Olympus Recalls High-Flow Insufflation Units

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Olympus recalls its high-flow insufflation units, warning that continued use of the devices could cause serious injury or death.

Partial Hold on MacroGenics Gynecologic Cancer Therapy

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FDA places a partial clinical hold on a MacroGenics Phase 2 (LINNET) trial of its investigational immunotherapy lorigerlimab after...

Preemption Defense Opportunities, Pitfalls

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Attorney Grant Hollingsworth outlines Trump administration changes that could positively or negatively affect a preemption defense...

FDA Cites Data Integrity, Quality Control at Aurobindo Facility

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FDA cites significant data integrity and quality control failures at an Indian manufacturing facility operated by Aurobindo Pharma...

FDA Accepts Sibel Aria Cough Sensor in DDT

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FDA accepts the Sibel Aria cough sensor into its Drug Development Tool qualification program.